Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of pdt vs rfa vs pdt+rfa for the treatment of extrahepatic cholangiocarcinoma

Conditions: Extrahepatic Cholangiocarcinoma; Bile Duct Cancer

Summary: a median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable ehcc. for patients with locally advanced, unresectable ehcc, effective management of tumor growth is the only option to increase stent patency and survival time. in patients with cholangiocarcinoma, photodynamic therapy (pdt) is therapy that has been shown to improve stent patency and overall survival (os). endoscopic radiofrequency ablation (rfa) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . in the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.

the lower common bile duct and the hepatic hilar area are the origin of extrahepatic cholangiocarcinoma (ehcc). patients with advanced, unresectable ehcc have a relatively poor prognosis, with a median survival time of 3 to 6 months. the only way to prolong stent patency and survival for patients with unresectable locally advanced ehcc is by active control of tumor development. the only treatment that has consistently demonstrated an improvement in stent patency and overall survival (os) in cholangiocarcinoma patients is photodynamic therapy (pdt). the popularity of endoscopic retrograde cholangio-pancreatography (ercp)-guided radiofrequency ablation (rfa) has grown recently in an effort to increase stent patency and survival time for patients with malignant biliary obstruction.rfa for biliary cholangiocarcinoma has demonstrated safety and effectiveness. endoscopic rfa has been shown in various studies to prolong stent patency and the survival of patients with malignant biliary obstruction. the clinical effectiveness and adverse events of these two endoscopic treatments have not been compared in many papers.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed cholangiocarcinoma; * unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (ct), magnetic resonance cholangiopancreatography (mrcp), or endoscopic ultrasound（eus）; * no previous treatment; * adequate bone marrow and organ function (white blood cells\>4.0×109/l, hemoglobin\>90 g/l, and platelets\>75×109/l, serum creatinine\<2.0 mg/dl); * a karnofsky performance status (kps) score ≥ 50; * signed written informed consent. exclusion criteria: * imaging examination (ct, mrcp, eus) showed distant metastasis of liver, lung and other organs; * coexistent with other malignant tumors; * pregnant or nursing women; * previous gastrointestinal diversion; * participation in another study during the month before enrollment in this study; * alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.

Keywords: extrahepatic cholangiocarcinoma photodynamic therapy radiofrequency ablation
a comparison of crystalloid alone versus crystalloid plus colloid in shock resuscitation

Conditions: Hypotension and Shock

Summary: fluid resuscitation is the most effective treatment of shock. isotonic crystalloid solution is the current recommended initial fluid resuscitation. however, this kind of fluid has high volume of distribution and may require large volume administration before achieve therapeutic goal of shock reversal. there are rising concern about the delay in shock reversal and adverse consequences of large amount volume of fluid therapy. colloid fluid have been used as the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and promote shock reversal. whether colloid infusion can improve shock reversal rate and decrease complication associated with fluid resuscitation, had inconclusive information.

fluid resuscitation is the most effective treatment of shock. isotonic crystalloid solution is the current recommended initial fluid resuscitation. however, this kind of fluid has high volume of distribution and may require large volume administration before achieve therapeutic goal of shock reversal. there are rising concern about the delay in shock reversal and adverse consequences of large amount volume of fluid therapy. colloid fluid have been used as the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and promote shock reversal. data from a recent randomized controlled study showed the improve long term survival among shock patients whose resuscitated with colloid solution. there were evidence about the increase incidence of acute kidney injury among critically ill patients who received hydroxyethyl starch, a previously worldwide used colloid solution. for septic shock, the leading cause of shock in current situation, resuscitation with albumin may associated with better outcome, while increasing mortality had been reported among the patient who received hydroxyethyl starch. whether colloid infusion can improve shock reversal rate and decrease complication associated with fluid resuscitation, had inconclusive information.

Eligibility criteria:
inclusion criteria: * age at least 18 years old * new onset of shock within 24 hours * mean arterial blood pressure less than 65 mmhg or systolic blood pressure less than 60% of patient's baseline blood pressure * evidence of poor tissue perfusion including: urine output less than 0.5 ml/kg/hr, lactate more than 2 mmol/l, alteration of consciousness without other explanation * evidence of fluid inadequacy (cvp \ 15%, pulse pressure variation \> 15%, positive fluid challenge test) exclusion criteria: * prolong shock more than 24 hours * received colloid solution more than 1,000 ml in previous 72 hours * do not resuscitation documented patient * contraindication for fluid therapy including: suspected cardiogenic shock, evidence of pulmonary edema, history of anaphylaxis after fluid therapy

Keywords: shock resuscitation colloid crystalloid
implementation of therapy together

Conditions: Cerebral Palsy; Hemiplegic Cerebral Palsy

Summary: the goal of this clinical trial is to learn about the implementation of therapy together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. the main question\[s\] it aims to answer are: * is the therapy together program effective in improving hand function and occupational performance compared to usual care? * is it feasible to implement the therapy together program within the standard care, early intervention framework? participants will participate in an 8-week pediatric constraint-induced movement therapy program. researchers will compare the group completing the therapy together program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.

a randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing therapy together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of therapy together within early intervention. therapy together program: the therapy together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. the child and caregiver complete 8 sessions with their therapist. the therapist is trained to educate the caregiver on the therapy together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. the first 7 intervention visits focus on constraint-induced movement therapy (cimt) and the final intervention visit focuses on bimanual therapy (use of two hands).

Eligibility criteria:
inclusion criteria: * at risk for developing cerebral palsy or have been diagnosed with cerebral palsy * children ages 3 months to 5 years 11 months * present with asymmetric hand use * present with a unilateral upper limb impairment * able to visually attend to objects * demonstrate an interest in objects * attempt to reach for or grasp objects with the impaired upper extremity exclusion criteria: * uncontrolled epilepsy * significant visual impairment * severe behavioral problems * inability to complete the assessment protocol.

Keywords: constraint induced movement therapy caregiver coaching
wishing to decrease aquaresis in adpkd patients treated with a v2ra; the effect of regulating protein and salt

Conditions: Polycystic Kidney, Autosomal Dominant; ADPKD; Autosomal Dominant Polycystic Kidney

Summary: this study evaluates the effect of regulating salt and protein intake on urinevolume in patients with adpkd treated with a vasopressine v2 receptor antagonist (v2ra). the investigators hypothesize that changing sodium and protein intake will reduce v2ra-induced polyuria.

autosomal dominant polycystic kidney disease (adpkd) is characterized by the formation of numerous cysts in both kidneys and progressive renal function decline leading to renal replacement therapy (rrt) at a median age of 58 years. the first (and at the moment only) drug to slow down renal function decline, is a vasopressin v2 receptor antagonist (v2ra). this medicament slows renal function decline by 26 to 34%. v2ra also causes aquaresis associated side-effects such as polyuria of \>6 liter per day in the majority of patients. these side-effects limit wide spread use among adpkd-patients. therefore, there is a need to improve its tolerability. while using a v2ra, urine concentrating ability is strongly diminished. therefore, urine volume is largely determined by total osmolar excretion. this is a well-known fact in nephrogenic diabetes insipidus, a disease with clear pathophysiological similarities to treatment with a vasopressin v2 receptor antagonist (a defect receptor versus pharmacological blockade). a recent study found osmolar excretion to be associated with urinary volume during v2ra treatment. whether a change in osmolar load changes polyuria during v2ra has not yet been investigated. the investigators hypothesize that changing sodium and protein intake will reduce polyuria.

Eligibility criteria:
inclusion criteria: 1. diagnosis of adpkd (ravine criteria/documented by nephrologist) 2. stable treatment regimen of tolvaptan as part of routine clinical care in the highest dose tolerable (preferably 120 mg daily), with a urine osmolality lower than 250 mosmol/l. 3. age \>= 18 years. 4. egfr \>30 ml/min/1.73m2. 5. providing informed consent. 6. compliance to the recommended diet at two consecutive times. exclusion criteria: 1. patients who, in the opinion of the investigator may present a safety risk. 2. patients who are unlikely to adequately comply to the trial's procedures (due for instance to medical conditions likely to require interruption or discontinuation, history of substance abuse or non-compliance). 3. a. patients taking medication likely to confound endpoint assessments: * lithium in any dosing regimen; * chronic use of systemic corticosteroids in any dosage; * chronic use of any diuretics in any dosing regimen; * daily use of any nsaids in any dosing regimen; 3. b. patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed or diabetes insipidus). 4. women who are pregnant or breastfeeding. 5. patients with a blood pressure over 160/100 mm hg at baseline.

Keywords: adpkd aquaresis vasopressine v2 receptor antagonist diet
predicting 28-day mortality in subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the investigators investigated the predictive ability of clinical and radiological scores, including the glasgow coma scale (gcs), hunt-hess, world federation of neurological surgeons (wfns), and modified fisher scales, as well as combined clinical scores such as the vasograde and ogilvy-carter rating scales, for 28-day mortality in patients presenting to the emergency department (ed) with non-traumatic subarachnoid hemorrhage (sah). specifically, we tested the hypothesis that combined clinical scores are more reliable and superior to non-combined clinical and radiological scores in predicting 28-day mortality in non-traumatic sah.

patients were divided into survivors and non-survivors, with surviving patients further categorized as either mobile or immobile based on the glasgow outcome scale. accordingly, patients who were dependent on daily support or in a coma were classified as immobile, whereas patients who had returned to normal life or were independent in their daily activities were classified as mobile. the demographic (age and sex), comorbidities (hypertension, diabetes mellitus \[dm\] and/or coronary artery disease \[cad\]), vital signs (systolic blood pressure, heart rate, respiratory rate, and peripheral capillary oxygen saturation \[spo2\]), and clinical assessment tools (gcs, hunt hess, wfns, modified fisher, vasograde, and ogilvy-carter rating scales) on admission were compared between the groups to identify factors associated with 28-day mortality and neurological survival. independent predictors of mortality were determined by multivariate logistic regression analysis of variables (demographic characteristics, clinical characteristics, and trauma scores) that differed significantly between survivors and non-survivors. an area under the curve (auc) analysis was then conducted to identify which trauma score is the most reliable and superior predictor of mortality.

Eligibility criteria:
inclusion criteria: * patients (aged ≥ 18 years) who presented to the emergency department with non-traumatic subarachnoid hemorrhage between september 2020 and september 2023 exclusion criteria: * patients younger than 18 years * patients with missing information * patients with traumatic sah * patients with subdural or epidural hemorrhage * patients with concurrent ischemic stroke

Keywords: subarachnoid hemorrhage aneurysmal non-traumatic glasgow coma scale world federation of neurological surgeons scale modified fisher scale vasograde scale ogilvy-carter scale 28-day mortality
decision aid for cigarette smokers undergoing surgery

Conditions: Tobacco Abuse

Summary: smokers have three choices when faced with surgery: keep smoking, quit for a short time around surgery or quit for good. in the first specific aim, a decision aid was designed to help facilitate the discussion of these choices between smokers and healthcare providers. this second aim will test whether this decision aid improves the decisional quality compared with standard methods used to discuss perioperative smoking.


Eligibility criteria:
inclusion criteria: * current cigarette smoker * scheduled to undergo elective surgery at mayo clinic rochester * age 18 years or older * able to fully participate in all study aspects exclusion criteria: * unavailable for telephone follow-up

Keywords: cigarette smoker elective surgery
short-term antibiotic treatment for unexplained fever in solid cancer patients with febrile neutropenia

Conditions: Febrile Neutropenia

Summary: the purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.

febrile neutropenia remains a major cause of morbidity in solid cancer patients. there is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. current guidelines recommend at least seven days of antibiotic treatment. several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. we plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol

Eligibility criteria:
inclusion criteria: * adults \>18 years providing signed informed consent * patients with solid tumors, lymphoma, multiple myeloma or chronic lymphocytic leukemia, regardless of disease status or previous chemotherapy * documented febrile neutropenia * no clinically or microbiologically documented infection after 72 hours exclusion criteria: * previous enrollment in this study * concurrent participation in another interventional trial * severe sepsis or septic shock * acute leukemia, autologous or allogeneic hematopoietic stem-cell transplantation * diarrhea suspected by treating physician to be irinotecan induced * any antibiotic treatment for \>48h in the last week before enrollment

Keywords: febrile neutropenia unexplained fever duration short-term antibiotic treatment
french observational survey to assess hypoglycaemia in insulin-treated diabetic patients

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this non-interventional study is conducted in europe. the study is both retrospective and prospective. the purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes mellitus * patients treated by insulin for at least 12 months * patients able to perform capillary self-monitoring plasma glucose (smpg) measurements * patients able to complete the questionnaires * patients who have accepted to participate to the survey (signature of an information notice) exclusion criteria: * patients with type 2 diabetes mellitus not treated with insulin * females who are currently pregnant or lactating or who were pregnant during the previous year
hydroxychloroquine to prevent sars-cov-2 infection/covid-19

Conditions: SARS-CoV-2

Summary: the purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent sars-cov-2 infection among healthcare workers. participants will be randomized into two parallel groups. the first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of sars-cov-2. the second arm will evaluate the use of standard measures of protection for the prevention of sars-cov-2. the target enrollment is 320 participants. each study participant will be monitored for sars-cov-2 seroconversion in weekly visits or for the development of covid-19 symptoms for 8 weeks.


Eligibility criteria:
inclusion criteria: 1. healthcare workers in service during the covid-19 outbreak including medical, nurse, technical, and auxiliary staff. 2. negative rapid serologic and molecular testing for sars-cov-2. 3. written informed consent. exclusion criteria: 1. presents covid-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste. 2. prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin. 3. known cardiac disease or a history of prolonged qt syndrome. 4. known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate. 5. use of concomitant medications that are contraindicated with the use of hydroxychloroquine. 6. other reported medical conditions, such as glucose-6-phosphate dehydrogenase deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances, that make study participation not in the individual's best interest.

Keywords: sars-cov-2 infection hydroxychloroquine
aftercare for adolescents treated for alcohol abuse and dependence

Conditions: Alcohol Use Disorder

Summary: the study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(aud)

in this study 177 adolescents meeting criteria for alcohol use disorders (aud) received weekly cognitive-behavioral therapy group sessions. 144 completers were randomized into the 3 individual aftercare (ar) conditions noted above. manualized active interventions were composed of 5 sessions of integrated motivational enhancement and cognitive behavioral therapies. outcomes assessments were done at end of aftercare, 3-6-and 12 months post ac completion.

Eligibility criteria:
inclusion criteria: * adolescents between the ages of 13-18 years * meeting criteria for dsm-iv alcohol use disorders * able to comprehend and read english at the 5th grade level * participant and family member are willing to provide a locator information. * not planning to move out of state during the next 12 months exclusion criteria: * meet any substance dependence criteria other than nicotine or cannabis * meet life time diagnosis of schizophrenia * reported a suicidal ideation with a plan, suicidal attempt, or self-injurious behavior in the last 30 days * having a medical condition that may prevent them from consistently attending and constructively participating in treatment and aftercare

Keywords: alcohol alcohol use disorder cognitive-behavioral therapy brief phone aftercare intervention individual aftercare therapy
effects of fatigue and foot orthoses on lower extremity emg and biomechanics for individuals with flat foot

Conditions: Flexible Flatfoot

Summary: determine the effects of non-custom made foot orthoses on the kinematics, muscle activity and joint contact force after fatigue and compare the rate of fatigue in flexible flat foot with and without foot orthoses


Eligibility criteria:
inclusion criteria: * bilateral flexible flatfoot( navicular bone drop greater than 10 mm) exclusion criteria: * history of foot and ankle surgery, inflammatory joint disease * history of lower extremity injury in six months * known pathological or neurological disorders that could affect gait pattern
an extension study to assess the long-term safety of the genio® system

Conditions: Obstructive Sleep Apnea of Adult

Summary: the objective of this study is to assess the long-term safety of the genio® system in adult osa patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the genio is in a nyxoah sponsored clinical investigation. (serious) adverse device effects and device deficiencies in subjects previously implanted with a nyxoah genio implantable stimulator (is) and having the is still in-situ (with therapy activated or deactivated) will be collected. the main question it aims to answer is: what is the long term safety profile of the genio system? participants will be asked to refer back to the site per standard of care and report on any (serious) adverse device effects and device deficiencies that may have occurred.

the objective of this study is to assess the long-term safety of the genio® system in adult osa patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the genio is in a nyxoah sponsored clinical investigation. all subjects that have previously participated in a nyxoah sponsored clinical investigation in australia, and who are currently still implanted with an implantable stimulator (with therapy activated or de-activated) will be asked to participate in this long-term safety follow-up study and will be asked to report any (serious) adverse device effects and device deficiencies that may have occurred.

Eligibility criteria:
inclusion criteria: * subject voluntarily signed an informed consent form * subject is currently implanted with a genio® implantable stimulator (is), with therapy active or inactive, and was included in and subsequently exited a nyxoah sponsored clinical investigation (either by study completion or withdrawal). these studies include, but are not limited to blast osa (cl-gen-001203), better sleep (cl-gen-001908), dream (cl-gen-002033) or, subject is currently implanted with a genio® implantable stimulator (is) and accessing therapy via the tga special access scheme (sas). exclusion criteria: * none

Keywords: osa hgns hypoglossal nerve stimulation